The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) approval to Concept Medical’s Magic Touch Sirolimus Coated Balloon.
The coated balloon catheter has been developed to treat below-the-knee (BTK) atherosclerotic lesions in peripheral arterial disease.
Developed using the firm’s Magic Touch percutaneous transluminal angioplasty (PTA) balloon drug delivery technology platform, Nanolute Technology, Magic Touch PTA will help deliver sub-micron particles of Sirolimus to reach the deepest vessel wall layers.
The product secured its first IDE approval for Coronary in-stent restenosis (ISR) indication last September.
Concept Medical also received breakthrough device status for BTK for the Magic Touch PTA Sirolimus Coated Balloon Catheter from the FDA.
The IDE approval will enable the company to collect data on the Magic Touch PTA Sirolimus Coated Balloon’s safety and efficiency. This is expected to help secure a future premarket approval (PMA) for the product in the US.
The catheter, which has already received a CE mark, was broadly assessed in several clinical studies outside the US and has demonstrated better safety and efficacy results, stated Concept Medical.
It is presently being assessed in Europe in two randomised controlled trials (RCTs) for the BTK indication.
The LIMES RCT trial will compare the catheter against percutaneous old balloon angioplasty (POBA), while the Debate BTK Duell study will evaluate it against the Paclitaxel-coated balloon catheter.
An early investigator of the Magic Touch PTA Balloon Professor Edward Choke said: “The field of BTK angioplasty needs effective solutions to its problem of poor patency rates.
“This is an exciting phase III trial that will determine whether the novel Magic Touch PTA Sirolimus coated balloon can maintain the patency of BTK arteries for a longer period of time, compared with our current gold standard of plain balloon angioplasty.”